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Heart Failure NYHA Class IIIPhase 4RESTAGE-HFNCT01774656

Remission From Stage D Heart Failure

A Phase 4 study testing Pharmacological Treatment in people with Heart Failure NYHA Class III and Heart Failure NYHA Class IV, run by University of Louisville at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function after undergoing a standardized Left Ventricular Assist Device (LVAD) plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months. Read more about this study

Who is it for?
Ages 18 to 59 years
What is being tested?
Pharmacological Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
6 sitesUnited States
Study dates
Jan 2013to Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subject age between 18 - 59 years, inclusive
  • Subject indicated for DT or BTT
  • Subject with severe clinical heart failure resistant to intensive medical therapy and requiring LVAD implantation
  • Subject with LVEF < 25% and cardiomegaly at the time of LVAD implantation as documented by radionuclide or contrast ventriculography or by echocardiography
  • Subject with non-ischemic etiology (confirmed by angiography either within 2 years of implantation or prior to explantation)
  • Subject have undergone HM II implantation within prior 4 weeks or planned for a HM II implant
  • Subject has a history of HF < 5 years.

Who cannot join

  • Subject has evidence of active acute myocarditis confirmed by histology
  • Subject has a history of previous CVA resulting in significant fixed motor deficit limiting ability to perform exercise testing
  • Subject has been implanted with a mechanical aortic and/or mitral valve(s)
  • Subject had an aortic valve closure
  • Subject diagnosed with a hypertrophic obstructive cardiomyopathy or sarcoidosis
  • Subject with LVEDD below normal confirmed by surface echocardiogram (restrictive cardiomyopathy)
Show all 14Show fewer
  • Subject has irreversible multi-organ failure
  • Pregnant or lactating women or unwilling to utilize two reliable methods of birth control for women of childbearing age
  • Subject is diagnosed with a psychiatric disease, irreversible cognitive dysfunction or poor psychosocial issues that is likely to impair compliance with the study protocol
  • Subject with any condition, other than heart failure, that could limit survival to less than 2 years
  • Subject has a history of cardiac or other organ transplant
  • Subject is contraindicated to anticoagulation antiplatelet therapy
  • Subject requires acute or chronic renal replacement therapy (e.g. chronic dialysis) within 3 months prior to enrollment
  • Subject participating in any other clinical investigations involving another Mechanical Circulatory Support (MCS) device or heart failure related drug, or investigations which are likely to confound study results or affect study outcome.

Trial locations and contacts

6 sites in 1 country.

Chris Cunningham, PhD contact

chris.cunningham@louisville.edu

6 sites in 1 country

United States6 sites, 6 recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Barb Gus, RN BSN CCRC, 216-445-6552, GUSB@ccf.org

    Maria Mountis, D.O.

    Recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Terry Blanton, BSN, RN, mtblan02@louisville.edu

    Emma Birks, MD, PhD

    Recruiting

  • Montefiore Medical Center

    New York, New York, 10467

    Auris Brown, aubrowne@montefiore.org

    Johanna Oviedo, 718-920-8780, joviedo@montefiore.org

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Stacy Flickbohm, RN, 402-559-5127, stacy.fickbohm@unmc.edu

    Natalie Kamtz, 402-559-3293, natalie.kamtz@unmc.edu

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19140

    Judith Marble, Judith.Marble@uphs.upenn.edu

    J E Rame, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Ashley Elmer, ashley.elmer@hsc.utah.edu

    Craig Selzman, MD

    Recruiting

Other trials in United States

About this study

Official title: Remission From Stage D Heart Failure (RESTAGE-HF)

The purpose of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function after undergoing a standardized Left Ventricular Assist Device (LVAD) plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months.

Read the detailed description

The encouraging results from the LVAD based recovery series suggest that the significant hemodynamic unloading provided by the Mechanical Circulatory Support (MCS) in conjunction with aggressive pharmacological treatment may induce a profound reverse structural remodeling and in turn result in a curative alternative to a specific patient population with severe heart failure. The active identification and characterization of the patients with a high potential for full cardiac function recovery is of paramount importance. The development of a standard and simplified recovery protocol would ultimately lead to a larger bridge to recovery patient population. The primary objective of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function (remission from heart failure) after undergoing a standardized LVAD plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months. The secondary objectives of this study are twofold, first to determine the durability of sustained remission from HF following LVAD explantation at 12 months and up to 3 years and second to determine the predictors of recovery.

Being tested
Pharmacological Treatment
Keywords
heart-assist device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacological TreatmentDrug

    The pharmacological treatment intended to enhance reverse remodeling includes 4 drugs initiated immediately after weaning of inotropic support once achieving adequate end-organ recovery and titrated (against symptoms, potassium, and renal function) to the following maximum doses: lisinopril 40 mg daily; carvedilol 25 mg 3 times daily; spironolactone 25 mg daily; digoxin 125g daily, and losartan 150 mg daily.

Study groups in NCT01774656
Study groupRoleWhat they receive
HeartMate II plus Pharmacological TreatExperimentalThe HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta. The pharmacological treatment intended to enhance reverse remodeling includes 4 drugs initiated immediately after weaning of inotropic support once achieving adequate end-organ recovery and titrated (against symptoms, potassium, and renal function) to the following maximum doses: lisinopril 40 mg daily; carvedilol 25 mg 3 times daily; spironolactone 25 mg daily; digoxin 125g daily, and losartan 150 mg daily.
Receives: Drug: Pharmacological Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects who experience LVAD removal and subsequent freedom from mechanical circulatory support or heart transplantation

    Measured: 12 months

Secondary outcomes (8)

  1. The proportion of evaluable subjects meeting explant criteria and subsequently explanted

    Measured: 6 weeks, 3, 4, 5, 6, 9, 12-18 months

  2. The time course of reverse remodeling on a left ventricular assist device

    Measured: 6 weeks, 3, 4, 5, 6, 9, 12-18 months

  3. The time course and sustainability of reverse remodeling following LVAD explantation

    Measured: 12-18 months

  4. Predictors of recovery and device removal

    Measured: 6 weeks, 3, 4, 5, 6, 9, 12-18 months

  5. Changes in maximal and sub maximal exercise capacity

    Measured: 12-18 months

  6. Changes in renal function and hepatic enzymes

    Measured: 6 weeks, 3, 4, 5, 6, 9, 12-18 months

  7. Changes in EF measured at 6000RPM.

    Measured: 6 weeks, 4, 6, 9, 12-18 months

  8. Changes in quality of life, as measured by the EuroQoL (EQ5D)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01774656
Sponsor's protocol ID
RESTAGE-UL
Acronym
RESTAGE-HF
Status last verified
Apr 2017
First submitted
22 Jan 2013
Last updated
27 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Birks EJ, Drakos SG, Patel SR, Lowes BD, Selzman CH, Starling RC, Trivedi J, Slaughter MS, Alturi P, Goldstein D, Maybaum S, Um JY, Margulies KB, Stehlik J, Cunningham C, Farrar DJ, Rame JE. Prospective Multicenter Study of Myocardial Recovery Using Left Ventricular Assist Devices (RESTAGE-HF [Remission from Stage D Heart Failure]): Medium-Term and Primary End Point Results. Circulation. 2020 Nov 24;142(21):2016-2028. doi: 10.1161/CIRCULATIONAHA.120.046415. Epub 2020 Oct 26.

    PubMed 33100036

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pharmacological Treatment in people with Heart Failure NYHA Class III and Heart Failure NYHA Class IV, run by University of Louisville at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chris Cunningham, PhD (chris.cunningham@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects who experience LVAD removal and subsequent freedom from mechanical circulatory support or heart transplantation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01774656, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.

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